MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRANSEND .014 FLOPPY 300 CM ( IC 300 ); WIRE, GUIDE, CATHETER

Catalog Number	M003468150
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the device revealed that guidewire was bent along its length in multiple locations, and that the ptfe coating was peeled at the bend site at 197.5cm.During functional evaluation resistance was encountered while the guidewire was being advanced and withdrawn, and the guidewire torque was not smooth due to the anomalies found on the guidewire.From the condition of the guidewire it appeared that the guidewire has gone under excessive manipulation during the procedure.Information from the complaint indicated that the stent delivery system and the guidewire were confirmed to be in good condition prior to use, continuous flush was maintained, and the anatomy was severely tortuous.It was reported that the guidewire was used with a wingspan stent and the wingspan pusher wire was bent so that the guidewire could not be removed from the wingspan stent system.It is likely that the wingspan device was bent due to the severity of the anatomy causing the transend guidewire to become jammed, bent and the observed ptfe coating peeling.Based on the information available and device analysis, an assignable cause of procedural factors has been assigned to this investigation.
Event or Problem Description
Based on investigation of the returned product, it was found that the ptfe coating was peeled.There was no impact to the patient.

• Brand Name: TRANSEND .014 FLOPPY 300 CM ( IC 300 )
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; one boston scientific place; natick MA 01760
• MDR Report Key: 6355208
• Report Number: 3004859241-2017-00005
• Device Sequence Number: 738000
• Product Code: DQX
• UDI-Device Identifier: 08714729441748
• UDI-Public: 0108714729441748171802221018958421
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K022357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/22/2018
• Device Catalogue Number: M003468150
• Device Lot Number: 18958421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2017
• Initial Report FDA Received Date: 02/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2 WINGSPAN STENT (STRYKER)